GREENWOOD VILLAGE, Colo., Feb. 4, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) ("Ampio" or the "Company") today announced that the article reporting the results of its initial pivotal clinical trial of Ampion™ for the treatment of pain due to Osteoarthritis of the knee (OAK), was published in PLOS ONE, an international, rigorously peer-reviewed, open-access, online publication which covers primary research from any discipline within science and medicine, and is the largest (by volume) scientific journal in the world.
The article entitled: "A Randomized Clinical Trial to Evaluate Two Doses of an Intra-Articular Injection of LMWF-5A in Adults With Pain Due to Osteoarthritis of the Knee" details the successful efficacy and safety outcomes of the use of Ampion™ in a double blinded, placebo controlled randomized trial known as the SPRING study (clinicaltrials.gov NCT01839331).
In the SPRING study, a total of 329 patients were randomized and received treatment across 9 sites in the United States in order to investigate the safety and efficacy of two doses of a single IA knee injection of Ampion on joint pain in OA of the knee. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints, including clinically and statistically significant reductions in pain at 12 weeks in patients treated with Ampion™ compared to saline vehicle control.The recently published study concludes that Ampion™ is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee. This study represents a potential major breakthrough in identifying a treatment for pain due to moderate to severe OA, particularly in patients with severe osteoarthritis where no other safe and effective therapies exists prior to joint replacement.
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